NCT03709433

Brief Summary

This study is an open trial of acceptance and commitment therapy (ACT) groups combined with a mobile app for the treatment of Generalized Anxiety Disorder (GAD). The goal of this study is to evaluate if ACT groups and a mobile app are efficacious and acceptable in the treatment of GAD. Study hypotheses are:

  1. 1.Group ACT will lead to improvement in worry, anxiety, comorbid depression, functioning, and well-being.
  2. 2.Group ACT will also lead to improvement in theoretically relevant processes, namely psychological inflexibility, anxiety-related fusion, mindfulness, and progress towards values.
  3. 3.Combining a mobile app with group ACT will be credible, acceptable, and satisfactory to participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

1.5 years

First QC Date

October 9, 2018

Last Update Submit

June 5, 2020

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

  • Penn State Worry Questionnaire (PSWQ)

    The PSWQ is a 16-item self-report measure of problematic worry. The PSWQ has validity and reliability in clinical samples.

    At posttreatment (6-10 weeks after baseline)

Secondary Outcomes (27)

  • Penn State Worry Questionnaire (PSWQ)

    One month after the posttreatment survey is administered (10-14 weeks after baseline)

  • State-Trait Anxiety Inventory (STAI) - Trait Subscale

    At posttreatment (6-10 weeks after baseline)

  • State-Trait Anxiety Inventory (STAI) - Trait Subscale

    One month after the posttreatment survey is administered (10-14 weeks after baseline)

  • Beck Depression Inventory-II (BDI-II)

    At posttreatment (6-10 weeks after baseline)

  • Beck Depression Inventory-II (BDI-II)

    One month after the posttreatment survey is administered (10-14 weeks after baseline)

  • +22 more secondary outcomes

Study Arms (1)

ACT groups and mobile app

EXPERIMENTAL

Participants will receive six two-hour weekly sessions of acceptance and commitment therapy (ACT) in a group format. They will also access the ACT Daily mobile app, which helps participants practice ACT skills in the moment, for the duration of the study (10-14 weeks depending on when the participant completes the baseline assessment.) Sessions use metaphors, experiential exercises, and discussion to target core ACT skills: acceptance, defusion, present-moment awareness, self-as-context, values, and committed action. The mobile app includes metaphors and experiential exercises to aid with all of these skills except self-as-context. Participants will be asked to use the app to practice these skills and to complete behavioral commitments linked to their values between sessions.

Behavioral: ACT groups and mobile app

Interventions

ACT groups and mobile appBEHAVIORAL

See arm description.

ACT groups and mobile app

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Seeking treatment for worry
  • Fluent in English
  • At least 18 years old
  • Have no serious mental illness
  • Not currently receiving other treatment
  • Meeting diagnostic criteria for generalized anxiety disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utah State University

Logan, Utah, 84322, United States

Location

Related Publications (17)

  • Fleming, J. E., & Kocovski, N. L. (2014). MINDFULNESS AND ACCEPTANCE-BASED GROUP THERAPY FOR SOCIAL ANXIETY DISORDER: A Treatment Manual (2nd ed.). Retrieved from https://contextualscience.org/mindfulness_and_acceptancebased_group_therapy_for_1

    BACKGROUND

  • Boone, M. S., & Cannici, J. (2013). Acceptance and commitment therapy (ACT) in groups. In Pistorello, J., (Ed.). Acceptance and mindfulness for counseling college students: Theory and practical applications for intervention, prevention, and outreach. Oakland, CA: New Harbinger.

    BACKGROUND

  • Twohig, M. (2004). ACT for OCD: Abbreviated Treatment Manual. (Unpublished treatment protocol). University of Nevada, Reno.

    BACKGROUND

  • Hayes, S. C., Strosahl, K., & Wilson, K. G. (2012). Acceptance and Commitment Therapy, Second Edition: The Process and Practice of Mindful Change. New York: Guilford Press.

    BACKGROUND

  • Levin, M.E., Haeger, J. & Cruz, R.A. (In Press). Tailoring acceptance and commitment therapy skill coaching in-the-moment through smartphones: Results from a randomized controlled trial. Mindfulness.

    BACKGROUND

  • Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.

    PMID: 2076086BACKGROUND

  • Molina, S., & Borkovec, T. D. (1994). The Penn State Worry Questionnaire: Psychometric properties and associated characteristics. In G. C. L. Davey & F. Tallis (Eds.), Wiley series in clinical psychology. Worrying: Perspectives on theory, assessment and treatment (pp. 265-283). Oxford, England: John Wiley & Sons.

    BACKGROUND

  • Spielberger, C. D. (1983). State-Trait Anxiety Inventory (Form Y). Redwood City, CA: Mind Garden.

    BACKGROUND

  • Segal DL, Coolidge FL, Cahill BS, O'Riley AA. Psychometric properties of the Beck Depression Inventory II (BDI-II) among community-dwelling older adults. Behav Modif. 2008 Jan;32(1):3-20. doi: 10.1177/0145445507303833.

    PMID: 18096969BACKGROUND

  • Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.

    PMID: 22035996BACKGROUND

  • Herzberg KN, Sheppard SC, Forsyth JP, Crede M, Earleywine M, Eifert GH. The Believability of Anxious Feelings and Thoughts Questionnaire (BAFT): a psychometric evaluation of cognitive fusion in a nonclinical and highly anxious community sample. Psychol Assess. 2012 Dec;24(4):877-91. doi: 10.1037/a0027782. Epub 2012 Apr 9.

    PMID: 22486595BACKGROUND

  • Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.

    PMID: 12703651BACKGROUND

  • Smout, M., Davies, M., Burns, N., & Christie, A. (2014). Development of the valuing questionnaire (VQ). Journal of Contextual Behavioral Science, 3, 164-172.

    BACKGROUND

  • Hahn EA, DeWalt DA, Bode RK, Garcia SF, DeVellis RF, Correia H, Cella D; PROMIS Cooperative Group. New English and Spanish social health measures will facilitate evaluating health determinants. Health Psychol. 2014 May;33(5):490-9. doi: 10.1037/hea0000055. Epub 2014 Jan 20.

    PMID: 24447188BACKGROUND

  • Lamers SM, Westerhof GJ, Bohlmeijer ET, ten Klooster PM, Keyes CL. Evaluating the psychometric properties of the Mental Health Continuum-Short Form (MHC-SF). J Clin Psychol. 2011 Jan;67(1):99-110. doi: 10.1002/jclp.20741.

    PMID: 20973032BACKGROUND

  • Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

    PMID: 11132119BACKGROUND

  • Kelley, M. L., Heffer, R. W., Gresham, F. M., & Elliot, S. N. (1989). Development of a modified Treatment Evaluation Inventory. Journal of Psychopathology and Behavioral Assessment, 11, 235-247. doi:10.1007/BF00960495

    BACKGROUND

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Michael Twohig, PhD

    Utah State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking will be used.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants will receive the same active treatment (acceptance and commitment therapy groups and a mobile app)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 17, 2018

Study Start

September 17, 2018

Primary Completion

March 21, 2020

Study Completion

April 15, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)